A Second Slice of FPIES: A Single-Center Reappraisal of Pediatric FPIES.

BACKGROUND: Food protein-induced enterocolitis syndrome (FPIES) is being increasingly recognized as a non-IgE-mediated food allergy; however, it remains unclear if and how the presentation, diagnosis, and management of this disease has changed in recent years. OBJECTIVE: To reappraise the FPIES cohort at a large US pediatric tertiary referral center. METHODS: We performed a retrospective chart review of pediatric patients with FPIES (International Classification of Diseases, Tenth Revision code K52.21) diagnosed in our allergy/immunology clinics between 2018 and 2022. RESULTS: There were 210 children diagnosed with FPIES. Most were White (73.8%), non-Hispanic (71.4%), and male (54.3%) with private insurance (77.6%). Cow's milk was the most common food trigger (35.2%), with the earliest median age of onset of 5 months. The atypical FPIES rate was 13.8%. FPIES was accurately diagnosed in 54.3% at the first medical contact. The oral food challenge pass rate was 73.5%. The rate of trigger resolution at 36 months was 77%. CONCLUSIONS: By comparing trends from a previous and current FPIES cohort, we were able to assess the potential impact of various guidelines and practice changes on the diagnosis and management of FPIES at our center. Milk and oat surpassed rice as the most common FPIES triggers; peanut and egg emerged as new FPIES triggers; there was a shorter time to diagnosis and an increased rate of atypical FPIES. Our findings reflect earlier recognition of FPIES and prompt allergy/immunology referral from community physicians, implementation of recent medical society guidelines for infant feeding practices, and growing clinical expertise of allergists at our center.

Reporting of harm and safety results in randomized controlled trials published in 5 dermatology journals.

BACKGROUND: Randomized controlled trials (RCTs) are considered the gold standard for assessing efficacy and short-term harm of medicines. However, several studies have come to the conclusion that harm is less well reported than efficacy outcomes. OBJECTIVE: To describe harm reporting in publications on dermatological RCTs and assess parameters that could influence the quality of harm reporting. METHODS: Methodologic systematic review of dermatologic RCTs published from 2010 to 2014 in 5 dermatological journals. RESULTS: Among 110 assessed publications on RCTs, 80 (73%) adequately reported harm and 52% adequately reported its severity. Overall, 40% of the assessed manuscripts perfectly reported and discussed harm. The adequate reporting of harm was significantly associated with the type of trial (odds ratio [OR] 4.41, 95% confidence interval [CI] 1.60-12.35 for multicenter compared with monocentric trials) and having a predefined method for collecting harm data (OR 5.93, 95% CI 2.26-15.56). Reporting of harm severity was better in pharmacologic trials (OR 6.48, 95% CI 2.00-21.0) compared with nonpharmacologic trials and in trials for which a method for collecting harm (OR 5.65, 95% CI 2.00-16.4) and its severity (OR 3.60, 95% CI 1.00-12.8) was defined before the study onset. LIMITATIONS: Assessment was restricted to RCTs and 5 dermatological journals. CONCLUSION: Harm is quite well reported in dermatologic journals. Efforts should be made on reporting severity of harm.

Insomnia: the Sleeping Giant of Pediatric Public Health.

Insomnia among children and adolescents is ubiquitous and takes a great toll on youth and their families, impacting academic achievement, mood, social functioning, and a variety of developmental outcomes. Unfortunately, however, pediatric insomnia most often remains unidentified and untreated. When treatment is provided, it is most often in the form of medications, which are not FDA approved for that indication in children and adolescents. A comprehensive literature review was employed to establish the recommendations in this report. This article provides a review of sleep physiology and both current and recommended approaches to assessing and treating pediatric insomnia. Comprehensive assessment, accurate diagnosis, and evidence-based treatment of insomnia is imperative to the healthy development of children and adolescents. While clinicians often prescribe a variety of medications to treat pediatric insomnia, there is insufficient data to demonstrate efficacy and endorse their routine use. At this time, behavioral techniques, such as cognitive behavior therapy for insomnia and sleep hygiene education, should remain the first line of treatment. As a second-line consideration, melatonin, a dietary supplement, may be effective. Pediatric insomnia has an enormous impact on children, adolescents, and their families that requires adequate attention from clinicians and parents alike.

Management of nonimmediate hypersensitivity reactions to drugs.

Nonimmediate hypersensitivity to drugs has a huge diversity of clinical presentations affecting exclusively or predominantly a single organ (most often the skin) or multiple organs. The latter is the rule with drug reaction with eosinophilia and systemic symptoms, and with drug-induced vasculitis. The management includes a dozen successive steps. Finally, the patient should be provided clear information on the suspected cause of the reaction, recommendations for follow-up after severe reactions associated with a risk of sequelae, and clear recommendations for future use of medications. Pharmacovigilance networks should be informed.

Severe cutaneous adverse reactions to drugs: from patients to the national office for compensation of medical accidents.

BACKGROUND: Administrative bodies for compensating medical accidents were created in France in 2002. OBJECTIVES: To evaluate the knowledge patients with severe cutaneous adverse reactions (SCARs) have of procedures and to compare the rate of compensation for SCARs for France and for our referral center. METHODS: A questionnaire was sent to 247 patients of our SCARs referral center and 225 patients with Stevens-Johnson syndrome and toxic epidermal necrolysis from the patient association AMALYSTE. We calculated the rate of compensation for France and our center. RESULTS: Among the 123 respondents (26%), 28 (23%) knew the compensation procedure; 13 (11%) had received compensation. The Commission of Conciliation and Compensation had received 63 applications for SCARs since 2002 and proposed compensation for 56%. The estimated rate of compensation for France was 2.6% and 2.5% for our referral center (p = 0.9). CONCLUSIONS: The procedure of compensation for SCARs is misunderstood. Better information should be disseminated for patients with threshold disability conditions.

Stevens-Johnson syndrome/toxic epidermal necrolysis: are drug dictionaries correctly informing physicians regarding the risk?

BACKGROUND: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) are severe drug reactions associated with high mortality and multiple incapacitating sequelae. In the past 20 years, two large multinational case control studies, published in 1995 and 2008, had identified different degrees of drug association with SJS/TEN: 'strongly associated', 'associated', 'suspected' and 'not suspected' medications. OBJECTIVE: The aim of this study was to check the adequacy of mention of risk of SJS/TEN in the drug dictionaries most widely used by physicians in five European countries. STUDY DESIGN: In each country one expert investigator looked at the most widely used drug dictionary (2009 edition) for mentions of risk of SJS/TEN. This was done for a predefined list of medications with a different degree of risk. The presence and clarity or absence of warning was compared with available evidence provided by published results from case-control studies. SETTING: The five countries participating in the RegiSCAR group: Austria, France, Germany, The Netherlands and the UK. RESULTS: A total of 3,268 drug descriptions of medications for systemic use were analysed, including all brands of 14 'strongly associated' drugs, 5 'associated' drugs and 12 widely used drugs with no established association. Discrepancies were found by country, and between descriptions for different brands of the same generic. Among 522 descriptions of 14 'strongly associated' drugs, only 5 did not mention the risk. For the 1,013 descriptions of 'associated' drugs, 3 % did not mention the risk. One-third of 'not suspected' drugs contained a specific or less specific warning (e.g. bullous cutaneous eruption). Warnings for 'strongly associated' medications were often as imprecise as those for 'not suspected' drugs. CONCLUSION: Information on the risk of SJS/TEN in drug dictionaries needs improvement to enhance the quality of advice given by general physicians and to raise the understanding of risk by patients.